Exec Director, API Synthetic Development

About this role

Who We Are: Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit  neurocrine.com , and follow the company on  LinkedIn ,  X , Facebook and YouTube . ( *in collaboration with AbbVie )

At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.

 About the Role: Directs the route selection, design, and scale-up of pharmaceutical ingredient (API) processes – inclusive of instruments and equipment - from the laboratory through pilot and manufacturing scale. Manages the science and engineering underlying the development and implementation of processing technologies and products to achieve cost effectiveness and improved product quality. Independently conducts synthesis and process development activities for preclinical and clinical candidates, including laboratory experimentation for compound preparation. Plans and implements the development of new process formulas, establishes operating equipment specifications and may advise manufacturing techniques and process equipment changes. Acts as liaison with Research and/or Commercial to ensure processes and designs are appropriate for the customer. Selects, develops, and evaluates personnel to ensure the efficient operation of the department. Works on challenges of significant scope in which analysis of situation or data requires executive review and discussion. _ Your Contributions (include, but are not limited to): • Drives strategic vision and direction for API Development

• Directs the design and scale-up of processes, instruments and equipment from the laboratory through pilot plant and manufacturing scale-up

• Manages the science and engineering underlying the development, implementation, and maintenance of process methods and equipment for the production of process formulas, technologies and products to achieve cost effectiveness and improved product quality

• Plans and implements the development of new process formulas, establishes operating equipment specifications and improves manufacturing techniques and new process equipment production

• Acts as liaison with research and/or development to ensure processes and designs are compatible. Selects, develops and evaluates personnel to ensure the efficient operation of the function

• Supports off-site synthesis and interaction with scale-up/ manufacturing contractors

• Effectively documents research and conducts work in a safe manner in accordance with company and departmental guidelines

• Performs other duties as assigned

• Interacts internally and externally with executive level management, requiring negotiation of extremely critical matters. Influences policy-making

• Leads multiple disparate groups and actively contributes to strategic planning for the larger function

• Partners with executive leadership team for the function to provide cohesive direction towards company goals

• Regularly interacts with vendors, regulatory bodies and other external stakeholders exerting influence and negotiating to drive business results

• Directs and controls the activities of multiple functional areas, divisions, product groups or service area

• Other duties as assigned

Requirements: • BS/BA degree in Chemistry or similar discipline and 16+ years of experience in pharmaceutical/ process development field and extensive previous leadership experiences also required OR

• Master's degree in Chemistry or similar discipline and 14+ years of similar experience noted above OR

• PhD in Chemistry or similar discipline AND 12+ years of similar experience noted above

• A thorough understanding of organic chemistry and process chemistry as well as current literature is required

• Manufacturing expertise in Chemical Development

• Good understanding of cGMP requirements in API manufacturing as demonstrated through past and present training and responsibilities

• Must have a demonstrated track record of managing multiple programs, resources and staff

• Must have extensive expertise in working with CRO/CMO's both as a lead and a team member

• Acts as a "trusted advisor" across the company and may be recognized as an external expert

• Provides strategy, vision and direction regarding issues that may have company-wide impact

• Requires in-depth knowledge of the functional area, business strategies, and the company’s goals

• Possesses industry-leading knowledge

• Must be self-motivated, detail-oriented, decisive

• Ability to quickly learn and think independently

• Excellent interpersonal & communication skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the Company

• Excellent managerial skills and experienc

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